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User manual
AUTOMATED EXTERNAL DEFIBRILLATOR
Manufacturer
Instramed Indústria Médico Hospitalar Ltda.
Industrial Unity:
Beco José Paris, 339 – Pavilhão 19
Postal code: 91140-310
Porto Alegre – RS, Brasil
Phone/Fax number: +55 51- 3073 8200
Email: [email protected]
Website: www.instramed.com.br
ANVISA 10242950010
European representative:
Obelis S.A.
Bd. Général Wahis 53, 1030, Brussels - Belgium
Phone: + 32.2.732.59.54
Fax: + 32.2.732.60.03
E-mail : [email protected]
ATTENTION: Instramed assumes no responsibility for any damage caused to
individuals or property brought by failure to use this product in accordance
with the information, recommendations and warnings presented in the user
manual, alterations made in the device, attempts of repair not provided by
authorized technical assistance centers, operation by unqualified personnel,
use of defective device or use of accessories and parts not supplied by the
manufacturer.
For information about warranty or technical assistance, please contact
Instramed’s technical support.
Copyright © 2015 Instramed. The Isis, Instramed and its respective logos are trademarks of Instramed Indústria Médico
Hospitalar Ltda. The internal software of this product is Instramed’s intellectual property, being protected under international
copyright laws. It is provided exclusively to be used with this present device, identified by the serial number, and may not be,
in whole or in part, evaluated, recompiled or altered in any way.
isis-user-manual-eng-r2.2-2015-08-10
II
Battery use
ATTENTION: Observe the battery charge maintenance instructions
First use:
The batteries are rechargeable Lithium-Ion (Li-ion). Before using it for the first time
the device must receive a full battery charge.
In order to do this, the equipment needs to be connected to an electric current for at
least eight hours.
To charge the battery connect the charger to the lateral connector in the device
and then to the electric current.
Time for full battery charge = 5 hours.
The device blocks any operation on the patient when connected to the electric
current.
Occasional use:
Even when disconnected (stand-by), the Isis executes internal routines checking
the status of the equipment. In spite of this procedure entailing a low power
consumption, the battery charge may be consumed.
Therefore, whenever the device has not been connected to an electric current for
more than 20 days, it is advisable to execute a full battery charge. If this procedure
is not performed, there is a risk of draining the battery and consequently being
unable to use the Isis in its portable configuration (not connected to the electric
current).
Replacement:
Every battery has a determined shelf life, which is the possible quantity of
full charge and discharge cycles, without loss of performance (see battery
specifications in chapter 8). When the device presents a drop in battery
performance, with low autonomy, please request a new unit from Instramed’s
technical assistance.
The batteries are rechargeable Lithium-Ion (Li-ion). The battery can be removed
by the side opening, in the lower left part identified by the symbol
(see picture
on page 22). Remove the screw, unplug the connectors from the battery, remove it
and replace it with the new set, observing the correct position of the connectors and
making sure the lid remains steady.
The battery’s shelf life is at least 500 cycles (full charges and discharges).
III
Package contents
Included items:
When opening the package, please check whether all items below are present:
• An Isis Automated External Defibrillator
• A power supply for charging internal battery
• A cable for connecting the power supply to the electric current
• A pair of disposable adult size adhesive pads
• A pair of disposable child size adhesive pads
• A user manual
• A first-aid kit
• A transport bag
• A USB cable
• A CD with the Soft DEA management Software
Replacement parts:
You can ask Instramed for replacements of the following items (consult Instramed
for prices. Shipping costs may be applied):
• Batteries replacement
• Adult/child adhesive pads replacement
To request pieces and services please contact Instramed.
IV
Index
Introduction09
Characteristics........................................................................................................... 09
Purpose..................................................................................................................... 10
Principle..................................................................................................................... 10
Use criteria................................................................................................................ 11
Qualified users........................................................................................................... 11
About the manual...................................................................................................... 11
Safety Information
12
Warnings................................................................................................................... 12
Adverse effects.......................................................................................................... 13
Standards.................................................................................................................. 13
Device care................................................................................................................ 14
Cleaning and disinfection.......................................................................................... 14
Connection to other equipment................................................................................. 14
Disposing of the device............................................................................................. 15
Precautions:............................................................................................................... 15
Classification and Symbols........................................................................................ 16
The Equipment
17
Front panel................................................................................................................ 17
1 - Indication of the stages of the defibrillation procedure.................................... 18
2 - Operational status indicator............................................................................ 19
3 - Start button...................................................................................................... 21
V
User manual | Index
Sides.......................................................................................................................... 22
1 - Speaker........................................................................................................... 23
2 - Battery power supply connector...................................................................... 23
3 - Battery compartment....................................................................................... 23
4 - USB Connector............................................................................................... 23
5 - Disposable pads compartment........................................................................ 23
6 - Disposable pads connector............................................................................. 24
7 - Cabinet recess................................................................................................ 24
Operation25
Operation cycle of the Isis......................................................................................... 25
Step 1................................................................................................................... 26
Step 2................................................................................................................... 27
Step 3................................................................................................................... 28
Step 4................................................................................................................... 29
Step 5................................................................................................................... 30
Applying CPR............................................................................................................ 30
Using the Isis on children under 8 years old.............................................................. 32
Simplified diagram of procedure in adults................................................................. 33
PC Connection
35
Introduction................................................................................................................ 35
Requirements............................................................................................................ 35
Soft DEA Installation.................................................................................................. 36
Connecting the Isis to a PC....................................................................................... 36
VI
User manual | Index
Operating Soft DEA
37
Startup screen........................................................................................................... 37
1 - Graphic display button.................................................................................... 37
Graphic display screen.............................................................................................. 38
1 - Download........................................................................................................ 38
2 -Open................................................................................................................ 38
3 - Print................................................................................................................. 39
4 - PDF................................................................................................................. 39
5 - Amplitude selection......................................................................................... 39
6 - Time frame...................................................................................................... 39
7 - Time frame scroll............................................................................................. 39
8 - Amplitude scroll............................................................................................... 39
9 - Event viewer window....................................................................................... 39
Adjustments............................................................................................................... 41
1 - Update clock................................................................................................... 41
2 - Volume level.................................................................................................... 41
Changing languages.................................................................................................. 42
Other buttons............................................................................................................. 42
1 - Back................................................................................................................ 42
2 - Exit.................................................................................................................. 43
Precautions, restrictions and warnings
44
Electromagnetic Compatibility (warnings and notices).............................................. 44
Electromagnetic emissions........................................................................................ 45
Electromagnetic immunity - General .......................................................................... 46
Electromagnetic immunity - Equipment with life support functions .................................... 47
VII
User manual | Index
ECG analysis algorithm............................................................................................. 49
Types of arrhythmia analyzed.................................................................................... 51
Specifications
52
General specifications............................................................................................... 52
Environmental specifications..................................................................................... 53
Defibrillator................................................................................................................ 53
Precision of applied energy:...................................................................................... 55
Patient’s impedance response table:......................................................................... 55
ECG rhythm recognition and detector table:............................................................. 55
Inspection and Maintenance
59
Preventive Maintenance............................................................................................ 59
Corrective Maintenance............................................................................................. 59
Warranty Certificate
60
VIII
1
Introduction
Given the complexity of the clinical variables involved, for many years only doctors
and experienced paramedics could use defibrillators to reverse a cardiac arrest.
Nowadays, however, with the evolution of artificial intelligence (AI), the Isis, using
its Neural Network Technology, is capable of analyzing the state of the patient,
considering the clinical variables and applying, automatically, the most suitable
shock therapy.
This allows any individual with proper training to perform assistance to a victim in
the process of fibrillation, multiplying and making life-saving possibilities easier.
Characteristics
• Semi-automatic.
• Artificial Intelligence: accurate diagnosis of the patient’s conditions, indicating
shock delivery or not.
• Safety precautions: prevents accidental use in cases in which shock treatment is
not advisable or in healthy people.
• Operation with just one button.
• Orientation by voice and indicator lights.
• Internal recording of events.
• PC connection via USB.
• Software for connection, download and data management via PC.
• Biphasic shock.
• Automatic self-diagnosis of functions and battery.
• Use in hospital or extra-hospital environments including emergency rescue units.
09
User manual | Introduction
Purpose
The defibrillator is a device used for treating cardiac arrhythmias, situations in which
the heart loses the ability of keeping steady heartbeats, blood stops being pumped
and oxygen and nutrients do not get to the organs, starting a degenerative process
known as biological death.
Among the most common cases of cardiorespiratory arrest are ventricular fibrillation
(VF) and ventricular tachycardia (VT), and the most efficient treatment for these
kinds of cardiac dysrhythmia is electrical defibrillation, a technique by which
electrical shocks are applied to the anterior thoracic wall.
Obviously, the success of defibrillation depends on the metabolic conditions of the
myocardium. The more the ventricular fibrillation lasts, the greater the metabolic
deterioration is and, consequently, the fewer chances of the electrical shock
converting it into a steady rhythm.
However, if it lasts shortly, as in the cases of quickly assisted cardiac arrests, shock
response is almost always positive.
Therefore, the most important factor in survival is how fast treatment is delivered.
Ideally, treatment should not be delayed for more than four minutes from the
beginning of the defibrillation.
Principle
Defibrillation is the electrical shock therapy responsible for reversing cardiac arrest
caused by ventricular fibrillation or ventricular tachycardia without a pulse.
The Isis uses the BIPHASIC SHOCK technology, which is characterized by a
current which is released in a direction and, after a very short time, reverts in the
opposite direction.
During the defibrillation the whole myocardium is briefly depolarized by a strong
positive impulse and a negative one, of adjustable intensity (Biphasic Truncated
Exponential Shock). This impulse is used for eliminating atrial and ventricular
fibrillation and ventricular disturbances.
Compared to monophasic shock, the following advantages can be mentioned
regarding biphasic technology:
• Greater efficiency at ending ventricular fibrillation.
• Lesser damage to the myocardium, through the use of lesser energy intensity,
with attenuation of subsequent myocardial dysfunction.
• Fewer incidence of refibrillation.
10
User manual | Introduction
Source: Sociedade de Cardiologia do Estado de São Paulo – SOCESP, Revista
Socesp V.11, no 2.
Use criteria
The Isis, as well as any other Automated External Defibrillator, must only be
used if the following circumstances, as a whole, are presented:
• Unconscious victim or unresponsive to verbal or physical stimulus
• Not breathing
• No pulse (for professionals)
Other important considerations regarding the use of the Isis:
• Not recommended for children under one year old.
• Pacemakers may affect the device’s efficiency.
• Medicines in adhesive form must be removed before starting defibrillation.
• Hypothermic patients may not respond well to defibrillation.
• Once the removal of the patient is started, the defibrillation must be interrupted.
Qualified users
Shall be considered qualified users those who have had training in a recognized
institution in the use of automated defibrillators and CPR techniques Cardiopulmonary Resuscitation.
About the manual
The function of this guide is to explain how the Isis Automated Defibrillator series
works, alerting the user to safety risks.
The information contained in this manual belongs to Instramed and cannot be used
fully, or in part, without expressed written consent.
Instramed has the right to make any changes to improve this guide and the product
without prior notice.
This guide is a part of the Isis and must be kept for further reference.
11
Safety Information
ATTENTION
The following factors may cause ECG misinterpretation:
2
• Wrongly placed pads.
• Patient’s movements.
• Pacemaker (it may lessen the precision of the cardiac arrest detector).
• Radio frequency interference, including mobile phones.
• Excessive hair or wet skin in the application area of the electrodes.
• Pieces of clothing between skin and pads.
Warnings
IMPORTANT: This equipment may only be operated by qualified technical
personnel. Read this guide carefully before using the equipment.
WARNING: THE PATIENT MUST BE PLACED ON NON CONDUCTIVE
SURFACES. DO NOT USE WET OR METALLIC SURFACES AND, IF
NECESSARY, DRY THE CHEST BEFORE APPLYING THE SHOCK.
WARNING: DO NOT TOUCH THE PATIENT, THE EQUIPMENT, THE
ACCESSORIES NOR ANY METALLIC OR CONDUCTIVE SURFACE WHICH IS
IN CONTACT WITH THE PATIENT DURING THE DEFIBRILLATION.
WARNING: DO NOT CONNECT THE PATIENT TO THE ISIS WHEN THE
EQUIPMENT IS CONNECTED TO THE ELECTRIC CURRENT.
WARNING: THE PATIENT MUST BE COMPLETELY STILL DURING THE
CARDIAC RHYTHM ANALYSIS PHASE. DO NOT GIVE CARDIAC MASSAGE AT
THIS POINT.
WARNING: risk of explosion if the equipment is operated in the presence of
flammable liquids or gases.
WARNING: always check the general state of the equipment, the battery and
the accessories before using it.
NOTICE: each and every repair to the equipment can only be done by
Instramed’s authorized technical assistance centers.
NOTICE: The use of the Isis is restricted to one patient at a time.
NOTICE: The applied parts are protected against defibrillation discharge;
during discharge there may be baseline variation.
12
User manual | Safety Information
NOTICE: Avoid connecting the patient to several items of equipment at the
same time. The limits of current leakage may be exceeded.
NOTICE: The applied parts intended to come into contact with the patient
have been evaluated and comply with the directives and principles of ISO
10993-1.
NOTICE: when removing the equipment from the package, carefully verify if
there is any abnormality or visible damage in the device or its accessories,
caused by impact or mishandling during transportation. In case of
irregularities, please contact Instramed.
NOTICE: disposable accessories and any other components must be
disposed of according to the norms of hospital waste disposal.
Adverse effects
Superficial burns may occur to the patient’s skin on the area in contact with the
electrodes. To minimize this effect, apply the pads soon after removing their
protective envelope and press them firmly to the patient’s skin.
The skin should be dry, or electrical current leakage may happen, enlarging burn
area and reducing treatment efficiency.
Standards
The Isis was designed according to safety and performance standards, such as:
• NBR IEC 60601-1:1997 (IEC 60601-1:1995), Medical electrical equipment – Part
1 – General Requirements for Safety.
• EN 60601-1:1990, (Amendment, A1:1993, A2:1995, A13:1996) (IEC 606011:1988, A1:1991, A2:1995), Medical electrical equipment - Part 1 - General
Requirements for Safety.
• NBR IEC 60601-1-2:2006 (IEC 60601-1-2:2004), Medical electrical
equipment – Part 1-2 - General Requirements for Safety – Collateral standard:
Electromagnetic compatibility - Requirements and tests.
• EN 60601-1-2:2007 (IEC 60601-1-2:2007), Medical electrical equipment. General
requirements for basic safety and essential performance – Collateral standard:
electromagnetic compatibility - Requirements and tests.
• ABNT NBR IEC 60601-1-4:2004 (IEC 60601-1-4:2000) Medical electrical
equipment - Part 1-4: General Requirements for Safety – Collateral standard:
Programmable electrical medical systems.
13
User manual | Safety Information
• IEC 60601-1-4:2000 - Medical electrical equipment - Part 1-4: General
requirements for safety — Collateral standard: Programmable electrical medical
systems.
• NBR IEC 60601-2-4:2005 (IEC 60601-2-4:2002), Medical electrical equipment Part 2 - Particular requirements for the safety of cardiac defibrillators.
• EN 60601-2-4:2003 (IEC 60601-2-4:2002), Medical electrical equipment.
Particular requirements for safety. Particular requirements for the safety of
cardiac defibrillators.
• ANSI/AAMI DF80:2003: Particular requirements for the safety of cardiac
defibrillators (including automated external defibrillators).
• NBR IEC/CISPR11:1995, Electromagnetic compatibility: Irradiated and
Conductive.
Device care
Do not place the equipment where it may fall on the patient. Do not lift the
equipment by its cables or connections.
Place cables connected to the patient in order to restrict the possibility of
strangulation.
Always keep the equipment and its accessories clean and well maintained.
If you suspect a fall or external damage, do not use the equipment.
Cleaning and disinfection
Instramed recommends cleaning and disinfecting the equipment and its accessories
every three months, or shorter periods whenever excessive dirt or contamination is
noticed. See the procedures for cleaning and disinfection below.
External parts of the equipment:
• Remove the equipment from the electric current before cleaning it.
• Wipe the external part of the equipment with a cloth dampened with water and
neutral soap or isopropyl alcohol.
• Never immerse the defibrillator in liquids.
Connection to other equipment
When connecting the Isis to any device, ensure that the equipment is operating
correctly before clinical use. The equipment or accessories connected to the device
must be certified according to the IEC 950 standard for data processing equipment.
14
User manual | Safety Information
Disposing of the device
Avoid contamination of the environment, humans, or other equipment by making
sure to properly sterilize and decontaminate the equipment before disposing of it.
Refer to local regulations for the proper disposal of trash in your area. For countries
that follow European Guidelines, refer to 2002/96/CE.
Precautions:
Danger of EXPLOSION: Do not use the Isis in the presence of flammable
anesthetics.
Risk of ELECTRICAL SHOCK: Never open the equipment. When necessary,
this must be done by authorized individuals.
Do not use the equipment in the presence of magnetic resonance devices.
This equipment was designed to be resistant to electromagnetic interference.
However, equipment performance can be affected if in the presence of strong
sources of electromagnetic interference or radio frequencies, such as mobile
phones, radio communicators, etc.
15
User manual | Safety Information
Classification and Symbols
Symbol
Standard
Description
IEC TR 60878
Attention: only use according to the instructions of this manual
IEC TR 60878
Careful: dangerous high electrical voltage
IEC TR 60878
Power supply connector
IEC TR 60878
Non-ionizing radiation
-
USB connector
ISO 780
This side up
ISO 780
Fragile equipment
ISO 780
Maximum stacking of 4 units
ISO 780
Keep away from rain
ISO 7000
ISO 780
Minimum and maximum temperature
ISO 7000
Minimum and maximum atmospheric pressure
ISO 7000
Minimum and maximum relative humidity
IEC TR 60878
Recyclable paper
Directive 2002/96/CE
Remains of electrical and electronic equipment - Dispose of
separately from other disposables
Directive 93/42/EEC
Mark of conformity according to the European Community. “XXXX”
stands for the number of the certification authority.
IEC 60417-5031
Direct current
IEC 60417-5036
CF applied part - defibrillation proof
IEC 60417-5010
On/Off (push-push)
EN 980
Manufacturer
EN 980
European representative
EN 980
Serial Number
16
3
The Equipment
Front panel
2
1
3
AUTOMATED EXTERNAL DEFIBRILLATOR (AED)
1. Screen indicating the stages of the defibrillation procedure and ECG curve.
2. Operational status indicator.
3. Start button.
17
User manual | The Equipment
1 - Screen
The Isis presents the following items on the screen when connected to the patient:
BPM 080
CPR 00:47
ANALYZING...
Do not touch
the patient.
1
2
3
4
5
6
1. Heart beats per minute.
2. Orientation message.
3. ECG curve.
4. CPR interval counter: counts the interval between discharge delivery, helping in the
CPR (Cardiopulmonary resuscitation) massage.
5. Icon indicating the defibrillation stage.
6. Battery status.
18
User manual | The Equipment
2 - Operational status indicator
The Isis performs a full auto-test weekly, allowing the user to know the operational
status of the device. This status is informed by a visual indicator (see picture
below), voice messages and sound signals.
The automatic test is also performed when the device is switched on. Should any
problem be found, the voice message “problem with the automatic test” will be
emitted with the visual indicator of failure.
VISUAL INDICATOR
Shows that the device is operating and
ready for use.
Shows that the device DOES NOT
HAVE ENOUGH BATTERY CHARGE
TO OPERATE or has another internal
defect. Charge battery immediately. If
the indicator remains red, please call
technical assistance.
• Mains supply LED on means device is connected to the electric current.
• Mains supply LED blinking when in normal use means the battery needs
charging. In this state the Isis guarantees at least 3 full energy discharges.
• Battery LED on means internal battery is being charged. A blinking LED beside
this symbol means full charge.
Notice: EVEN WHEN THE BATTERY HAS BEEN FULLY CHARGED, the
operational status indicator will still be showing .
The display will only change from to when the Isis performs the auto-test routine or if the device is turned on/of by the user.
That is: to change the display from to user’s intervention is necessary after the battery has been completely charged.
19
User manual | The Equipment
ATTENTION: remember to check the status of the operational status indicator at least every 30 days.
SOUND INDICATOR
Along with visual indication, the Isis emits electronic beeps which can be identified
by the user from a distance and can also be interpreted according to the frequency,
as in the table below:
Number of beeps
Failure description
Two
CPU failure
Three
Failure in defibrillation module
Four
Discharged battery
Five
General failure in battery module
ATTENTION: the device will not switch on if the battery is discharged
or showing general failure. In this case only the sound warning of the
respective failure will be emitted.
20
User manual | The Equipment
3 - Start button
The Isis offers exclusive technology which allows to operate the device completely
safely with a single button.
Início
Switch on
Analyze
Start
Deliver shock
1st press
2nd press
The start button has the functions of:
• Turning on the device
• Starting the automatic process of the patient’s clinical analysis
• Applying shock therapy (active only when the automatic clinical analysis of the
patient indicates the need for it)
More information in the “Operation” section.
NOTE: it is not necessary to switch the Isis off. Fifteen seconds after the removal of pads from the patient or disconnection of pads from the equipment,
the device switches itself off, saving battery charge. In this moment the following message will be heard: “The device is being turned off. Press the button in
order to turn the machine back on”.
Still, there are three ways of switching it off manually: pressing the start
button for three seconds, removing the pads or plugging and unplugging
the USB cable.
21
User manual | The Equipment
Sides
4
1
5
6
2
7
3
1. Speaker
5. Disposable pads compartment
2. Battery power supply connector
6. Disposable pads connector
3. Battery compartment
7. Cabinet recess
4. USB connector
22
User manual | The Equipment
1 - Speaker
The Isis is a highly complex equipment which, from the moment of activation,
assesses the steps of the operation and the general state of the patient. Based on
this analysis, the device guides the user through verbal commands which may be
warnings, instructions or status messages. Therefore it is extremely important
that the speaker is unobstructed and the Isis is in a position which allows the
user to hear its instructions.
ATTENTION: do not use the equipment inside bags which may prevent
the user from hearing the spoken instructions.
2 - Battery power supply connector
Connect the power supply to the electric current and then, to this connector in order
to charge the internal battery. The equipment operates on voltage between 100 to
240 V in 50/60 Hz.
ATTENTION: the device performs internal routine verifications which
consume energy. Even when the equipment is not in use, a full charge is
recommended every 20 days.
3 - Battery compartment
It holds the internal batteries of the equipment. The reset button is also placed in
this compartment, in case restarting the equipment is necessary.
ATTENTION: in case of battery replacement, use original replacements
from Instramed supplied by its authorized distributors.
4 - USB Connector
Used for connecting the equipment to a PC (see chapter 5).
5 - Disposable pads compartment
Used for storage of disposable pads used in shock delivery.
ATTENTION: the disposable pads have an expiration date. Check the
expiration date on the wrapping, and in case they have not been used
during this period, replace them with another pair.
23
User manual | The Equipment
ATTENTION: only use original pads provided by Instramed. Not following
this observation may prevent the equipment from working.
6 - Disposable pads connector
Used for connecting disposable pads to the Isis.
ATTENTION: whenever the pads set is replaced, remember to keep a new
pair already connected to the equipment.
7 - Cabinet recess
Used for attaching the cord of the disposable pads to the equipment’s body,
preventing the cord from getting loose. When installing a new pair of pads, push the
connector’s cord in its narrowest part inside the cabinet recess and then twist to fix
it.
24
4
Operation
Operation cycle of the Isis
The Isis is an advanced and fully automated cardiac resuscitation equipment
(defibrillator). See below a simplified introduction of its operation. Memorize the
detailed guide on the next pages attentively before you operate the equipment.
3
2
Equipment analyzes
patient’s condition
4
Analysis is
concluded:
shock is
recommended!
Place
pads on
patient
Start
Início
Press button to
start cycle
Press button to
deliver shock
1
5
Shock delivered: start
CPR (cardiopulmonary
resuscitation)
6
The energy delivered is pre-adjusted. The user cannot change this protocol.
For adult electrodes: 1st shock: 150J, the following: 200J.
For child electrodes: 50 J.
25
User manual | Operation
Step 1
Before starting the operation, please call the emergency service.
If the disposable pads have not been connected to the Isis yet, attach the
connector to the plug on the right side of the equipment.
After disposing of used pads, always leave a replacement pair already
connected to the equipment, avoiding having to replace them at the moment of the emergency.
ATTENTION: this device has electronic safeguards and will not operate in
inadvisable situations.
Check patient’s condition. Only use the equipment if the patient is not
breathing.
26
User manual | Operation
Step 2
Remove pads from their wrapping and peel off the film protecting the
adhesive.
Place pads on the patient according to the picture above, keeping adhesive
area in contact with the skin.
This position allows the electric current to circulate from one pad to the other, thus
reaching the whole thoracic cage.
ATTENTION: the area in contact with the pads must be dry.
The presence of too much hair in the contact area may affect scanning. In
this case, shave hair.
ATTENTION: the pads must be applied directly over the skin. DO NOT
place pads over clothes.
ATTENTION: only open the wrapping and remove adhesive electrodes
immediately before use.
ATTENTION: a pair of adhesive electrodes can hold up to 50 defibrillation discharges. However, once used, even if only once, it is advisable to
replace them after 24 hours.
27
User manual | Operation
Step 3
3
2
Analyzing heart
rhythm...
Press “START” button.
The Isis will automatically enter cardiac rhythm analysis mode and will start giving
vocal instructions clearly and pausedly, so that the user can perfectly understand
them. Visual indications in each stage will also be demonstrated on an LCD screen.
ATTENTION: the patient must be on a steady surface. Any movement
during the process of clinical analysis will result in mistaken scans.
ATTENTION: the pads are disposable and can be used in only one patient
at a time. Remember to always keep extra ones with the equipment. For
replacements, please contact Instramed.
28
User manual | Operation
Step 4
Treatment
recommended. Don’t
touch the patient!
3
2
Push the flashing
button to treat the
patient.
If the need for shock is detected, the shock symbol will blink and the device will ask
the user to press the start button again.
Press “START” button again.
The shock will be delivered.
ATTENTION: the user must not touch the patient or conductive surfaces
in contact with him/her during shock delivery, under risk of suffering a
powerful electric discharge.
ATTENTION: disconnect other equipment which do not have defibrillation
protection before defibrillating the patient.
If clinical scans show that defibrillation is not recommended, the Isis will announce:
“TREATMENT NOT RECOMMENDED”.
Check whether there were patient’s movements during the analysis. If there were,
restart the process. If not, remove pads and start the CPR (cardiopulmonary
resuscitation) procedure. Details on the next section.
29
User manual | Operation
Step 5
30X
2 min.
2X
After the shock, start the CPR procedure.
CPR (cardiopulmonary resuscitation) is a technique which consists in mechanical
stimulation of the lungs and heart. Through simple actions, it aims to maintain the
oxygenation of the brain, avoiding irreversible damage.
Applying CPR
1. Lay the victim on his back on a hard flat surface.
2. Run your fingers from the center of the victim’s thorax, descending until finding
a bone that comes to a tip in the middle of the chest (Sternum), right above the
stomach.
3. Keep two fingers right below this point.
4. Place the palm of your other hand above the two fingers that indicate the base of
the Sternum bone. This is the correct spot for the massage.
5. Put one palm on top of the other, keeping your fingers curled up without touching
the thorax. In small children, however, use only your fingers. Apply force according
to the victim’s size.
30
User manual | Operation
6. Keep your arms stretched. Put pressure on the victim’s thorax, compressing the
chest and then releasing it. Follow the BEEPS emitted by the Isis, which mark
the rhythm of the compressions. Every 30 compressions, apply 2 mouth-to-mouth
ventilations.
7. Performing mouth-to-mouth breathing:
• Place one hand on the back of the victim’s neck and lift it; place your other hand
on the victim’s forehead and force the head back, in order to let the air through.
• Close the victim’s nostrils with the fingers which are on the forehead.
• Take a deep breath, and place your open mouth on the victim’s mouth (if it is a
child, also cover the nose with your mouth).
• Force air inside the victim’s lungs, until the thorax inflates, as in normal
breathing.
• Allow the person to release the air by removing your mouth.
8. At every interval to perform mouth-to-mouth breathing, check if the patient’s pulse
is back..
The massage and ventilation cycle must be done for two minutes. If the patient’s
pulse does not return, restart shock procedure with the Isis.
After the third complete CPR and shock cycle, chances of the patient’s resuscitation
are very slim.
31
User Manual | Operation
Using the Isis on children under 8 years old
The Isis can be used on children from the age of one year onwards. However, on
patients from one year of age to eight years of age or patients who weigh less than
25kg, some precautions must be taken:
• Use child pads;
• If the pads cannot be placed within the minimal distance of 4 centimeters
between them, place one of them on the child’s chest and another on his
back.
Larger
than
4 cm
(Chest)
Shorter than
4 cm
32
(Back)
User manual | Operation
Simplified diagram of procedure in adults
Healthcare professional
Unconscious
- Conscious
- Panting
Check patient’s condition
Not breathing
Wait for emergency
team
Call emergency
service
No pulse
Place victim on a dry, flat
and steady area
- Place pads
- Activate the Isis
Restarts the cycle
Recovers
pulse
+ breathing
Wait for emergency
team
The Isis analyzes
patient’s condition
Restarts the cycle
Shock NOT
recommended
Shock
recommended
CPR for 2 minutes
Move away from the patient
Activate AED
No pulse, no breathing
recovery
Shock delivered
CPR for 2 minutes
Recovers
pulse
+ breathing
Wait for emergency
team
33
User manual | Operation
Simplified diagram of procedure in adults
Layperson
Unconscious
Call emergency
service
- Conscious
- Panting
Check patient’s condition
Not breathing
Wait for emergency
team
Place victim in a dry flat
steady area
- Place pads
- Activate the Isis
Restarts the cycle
It recovers
breath and/or
movements
Wait for emergency
team
The Isis analyzes
patient’s condition
Restarts the cycle
Shock NOT
recommended
Shock
recommended
CPR for 2 minutes
Move away from the patient
Activate AED
It doesn’t recover breath
and/or movements
Shock applied
CPR for 2 minutes
It recovers
breath and/or
movements
Wait for emergency
team
34
5
PC Connection
Introduction
The Isis can be connected to a PC, allowing the user access to new functions as:
• View, save in external media or print list of the last 100 events.
• View, save in external media and print ECG activity of the last two hours.
• Change the operational configurations of the Isis (only for authorized technicians)
• Check and update firmware version of the equipment (only for authorized
technicians)
Requirements
Connecting the Isis to a PC requires installation of the Soft DEA application in the
computer to which a connection will be made. This software is in the CD which
comes with the equipment.
To install Soft DEA, observe the following requirements:
• Windows XP, Windows Vista or Windows 7 operating system
• CPU of 300 MHz or faster
• 02 GB free hard disk space
• Minimum 512 MB RAM (1 GB recommended)
• CD or DVD ROM reader unit
For physical connection to the PC:
• One available USB port
35
User manual | PC Connection
Soft DEA Installation
• Insert the software CD in the CD/DVD ROM drive.
• If the autorun does not start automatically, find the “softdeasetup.exe” file in the
CD and double-click it.
• Follow the installation instructions which will show up on the screen.
Connecting the Isis to a PC
• Connect the equipment only after installing Soft DEA.
• After the installation connect the device through the USB cable given.
• The location of the device drivers to be installed will be required. They can be
found in this folder: C:\Program Files\Instramed\Soft DEA\DRIVERS.
• Start the Soft DEA application.
• On the language selection screen, choose among Spanish, English or
Portuguese. You only have to select a language the first time you start the
software.
• After the software reads the Isis data (see following section), the ECG and the
events list will appear on the software’s screen.
ATTENTION: the equipment must not be connected to the patient when
communication via USB with the Soft DEA application occurs.
ATTENTION: the equipment blocks any operation on the patient when
communication via USB with PC occurs.
36
6
Operating Soft DEA
Startup screen
1
1 - Graphic display button
Click this button to display the ECG waveforms and event list
stored on the device. The displayed interval corresponds to the
user-defined time frame (see item 7 on page 39 of this manual).
37
User manual | Operating Soft DEA
Graphic display screen
1
2
3
9
4
5
7
6
8
1 - Download
The set of information that is currently being viewed can be saved
on the PC by clicking this button. A window will open enabling the
user to select the desired location in which to store the file.
download
2 -Open
Click this button to open a ".dea" file that was previously saved on
the computer.
open
38
User manual | Operating Soft DEA
3 - Print
Click this button to print the set of information that is currently
displayed on the screen. Use the printer driver dialog box to set
printing options.
print
4 - PDF
Click this button to generate a file showing the set of information
that is currently displayed on the screen in pdf format. The user
must select the desired directory in which to save the file.
PDF
5 - Amplitude selection
Allows the user to vary the ECG amplitude from 0.5 mV to 3.0 mV.
6 - Time frame
Allows the ECG to be viewed in time frames from 1 second to 60 seconds.
7 - Time frame scroll
Allows the ECG to be viewed throughout its time scale.
8 - Amplitude scroll
Allows the ECG to be viewed throughout its amplitude scale.
9 - Event viewer window
After downloading the information contained in the CardioMax memory, the list of
events stored by the device will be displayed in this area in chronological order.
Double click on an event to view it on the main screen.
Definition of events displayed in AED mode:
39
User manual | Operating Soft DEA
• INTERNAL DISCHARGE - Power discharged internally due to pressing the start
button for an excessive amount of time.
• TREATMENT PERFORMED - A shock was delivered to the patient.
• SHOCK INDICATED - Shock indicated due to the patient's ventricular fibrillation
or ventricular tachycardia pattern.
• SHOCK NOT INDICATED - Shock not indicated on account of the
electrocardiogram pattern not requiring a shock.
• ANALYZING AED - Analyzing heart rhythm.
• ASYSTOLE - Asystole detected.
• PADS DISCONNECTED - The pads were disconnected.
• CHILD PADS - Child pads were connected to the device.
• ADULT PADS - Adult pads were connected to the device.
• TURNED ON - The equipment was turned on.
• CPR - Equipment indicating the CPR procedure.
40
User manual | Operating Soft DEA
Adjustments
Click the settings button to access the screen that allows you to update the clock
and set the sound level emitted by the speaker on the equipment. In order to make
changes, the Isis/Isis PRO device must be turned on and connected to the PC
running Soft DEA, via the supplied USB cable.
1 - Update clock
Click the “update” button to synchronize the clock with the time on
the PC connected to the Isis/Isis PRO device.
update
2 - Volume level
Using the mouse, simply select one of the five volume presets for the equipment
audio.
41
User manual | Operating Soft DEA
Changing languages
1
2
• Under the "in the SoftDEA" option: Change the language of the software
interface. Does not require a device to be connected.
• Under the "in the device" option (when an Isis/Isis PRO device is
connected): Change the language of voice prompts emitted by the speaker on
the device to the selected language.
• Under the "in the device" option (when a CardioMax device is connected):
The CardioMax language can be changed through the device's settings menu
(see page 48 - "General setup"). However, if the voice prompts emitted by the
CardioMax device show signs of degradation or defects, this function can be
used to restore the equipment's speech synthesis files.
Other buttons
1 - Back
Click this button to return to the previous page/menu.
42
User manual | Operating Soft DEA
2 - Exit
Click this button to close Soft DEA 3.
43
Precautions, restrictions and
warnings
The Isis is a device built according to NBR and IEC standards and
therefore is completely safe for the patient and the user. However, all safety
precautions described below must be followed.
7
The operation of the Isis may be affected by the presence of electromagnetic
power supplies, such as electrosurgical equipment and computer
tomography (CT).
Electromagnetic Compatibility (warnings and notices)
WARNING: Using the Isis requires special precautions concerning
Electromagnetic Compatibility in compliance with the information contained
in this manual.
Mobile and portable RF communications equipment, such as a cellphones,
may affect the functioning of the Isis.
Maximum length of accessory cables in order to comply with the
requirements of Electromagnetic Compatibility is 2,5 m.
All parts and accessories which go with the equipment, listed below, follow
the requirements for Electromagnetic compatibility.
• Pair of disposable adhesive pads, adult size
• Pair of disposable adhesive pads, child size
• Power supply for charging internal battery
• USB cable
WARNING: using cables and accessories different from the ones specified
above, except for cables and accessories sold by Instramed as replacement
pieces, may result in emission gain or immunity decrease of the equipment.
The Isis must not be used too close to or piled over other equipment.
44
User manual | Precautions, restrictions and warnings
Electromagnetic emissions
Directives and manufacturer declaration - electromagnetic emissions
The Isis is intended for use in the specific electromagnetic environment below. The customer or user of the defibrillator is advised to
ensure that it is used in such an environment.
Tests
Compliance
Electromagnetic environment - directives
RF Emissions ABNT NBR IEC CISPR11
Group 1
The Isis only uses RF power for its internal functions.
Nevertheless, its RF emissions are very low and are not likely
to cause any interference in nearby electronic equipment.
RF Emissions ABNT NBR IEC CISPR11
Class B
Harmonics Emissions IEC 61000-3-2
Class A
Voltage fluctuations/flicker emissions IEC
61000-3-3
Complies
The Isis is suited for use in any establishment. This includes
residential establishments and those directly connected to the
public network of distribution of low voltage electricity which
supply domestic use buildings.
NOTE: It is of paramount importance that the true efficacy of the RF shielding and the true attenuation of the RF filter of the shielded
location are checked to ensure that they meet or exceed the minimum values specified.
45
User manual | Precautions, restrictions and warnings
Electromagnetic immunity - General
Directives and declaration of the manufacturer - electromagnetic emissions
The Isis is intended to be used in the specific electromagnetic environment below. The user or customer of the defibrillator should
ensure that it is used in such an environment.
Immunity Test
Test Level - ABNT NBR
IEC 60601
Compliance Level
Electromagnetic
Environment - Directives
Electrostatic discharge (ESD)
IEC 61000-4-2
± 6 kV contact
± 8 kV air
± 6 kV contact
± 8 kV air
Floors should be made of
wood, concrete or tiles. If floors
are covered with synthetic
material, the relative humidity
should be at least 30%.
Electrical fast transient/Burst
IEC61000-4-4
± 2 kV for power supply lines
± 1 kV for input/output lines
± 2 kV for power supply lines
± 1 kV for input/output lines
The quality of the power
supply should be that of a
typical commercial or hospital
environment.
Surge
IEC 61000-4-5
± 1 kV differential mode (phase
– phase)
± 2 kV common mode (phase
– ground)
± 1 kV differential mode (phase
– phase)
± 2 kV common mode (phase
– ground)
The quality of the power
supply should be that of a
typical commercial or hospital
environment.
Voltage dips, short
interruptions, and voltage
variations on power supply
input lines
IEC 61000-4-11
< 5% UT
(> 95% dip in UT) for 0,5 cycle
40% UT
(60% dip in UT) for 5 cycles
70% UT
(30% dip in UT) for 25 cycles
< 5% UT
(> 95% dip in UT) for cycle of
5 seconds
< 5% UT
(> 95% dip in UT) for 0,5 cycle
40% UT
(60% dip in UT) for 5 cycles
70% UT
(30% dip in UT) for 25 cycles
< 5% UT
(> 95% dip in UT) for cycle of
5 seconds
The quality of the power
supply should be that of a
typical commercial or hospital
environment. If the user of the
defibrillator requires continued
operation during power
interruption, it is advisable
that the Isis is supplied by an
uninterrupted power source or
a battery.
3 A/m
Power frequency magnetic
fields should be at
characteristic levels of a
typical commercial or hospital
environment.
Power frequency (50/60 Hz)
magnetic field
IEC 61000-4-8
3 A/m
NOTE: UT is the ac mains voltage prior to application of the test level.
46
User manual | Precautions, restrictions and warnings
Electromagnetic immunity - Equipment with life support functions
Advisable separation distances between mobile and portable RF communications equipment and the Isis
The Isis is intended to be used in the electromagnetic environment specified below. The customer or user of the defibrillator should
ensure that it is used in such an environment.
Immunity Test
Test Level of ABNT NBR
IEC 60601
Compliance Level
Electromagnetic Environment – Directive
Portable and mobile RF communications
equipment should not be used near any part
of the Isis, including cables, with a separation
distance less than the one advised, calculated
using the equation applicable to the frequency
of the transmitter.
Advisable Distance of Separation:
Conducted RF IEC
61000-4-6
Conducted RF IEC
61000-4-6
3 Vrms
150 kHz up to 80 MHz outside
bandsa ISM
[V1]V
10Vrms
150 kHz up to 80 MHz outside
bandsa ISM
[V2]V
10V/m
80MHz up to 2,5GHz
[E1]V/м
80 MHz to 800 MHz
80 MHz to 2,5 GHz
Where “P” is the maximum output power of
the transmitter in watts (W), according to the
transmitter manufacturer, and “d” is the advisable
separation distance in meters (m)b
Field strengths established by RF transmitters, as
determined by an electromagnetic site survey, c
should be less than the compliance level in each
frequency ranged.
Interference can occur around
equipment marked with
the following symbol:
NOTE 1: At 80MHz and 800MHz, the highest frequency range is applied.
NOTE 2: These directives may not be applicable in all situations. Electromagnetic transmission is affected by the absorption and
reflection of structures, objects and people
ISM bands (industrial, medical and scientific) between 150kHz and 80MHz are 6,765MHz to 6.795MHz; 13.553Mhz to 13.567MHz;
26.957MHz to 27.283MHz; and 40.66MHz to 40.70MHz.
The compliance levels in the ISM frequency bands between 150kHz and 80MHz and in the frequency range between 80MHz and
2.5GHz are intended to reduce the likelihood of mobile and portable communications equipment causing interference if inadvertently
brought into the patient areas. Therefore, an additional factor of 10/3 is used in calculating the advisable separation distance for
transmitters in these frequency ranges.
c
Field strengths established by fixed transmitters, such as base stations for radio, telephones (cell phone/wireless) mobile land
radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with any accuracy. In order to
evaluate the electromagnetic environment due to fixed RF transmitters, it is advisable to consider an electromagnetic site survey. If the
measured field strength in the site where the Isis is used exceeds the level of RF compliance used above, the Isis should be observed
to check if operation is normal. If abnormal performance is observed, additional procedures may be required, such as reorienting or
repositioning the Isis.
d
Over the frequency range 150kHz to 80MHz, the field intensity should be less than [V1]V/m.
a
b
47
User manual | Precautions, restrictions and warnings
Electromagnetic immunity - Life support function equipment
Advisable separation distances between mobile and portable RF communications equipment and the Isis
The Isis is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or
user of the defibrillator can help to prevent electromagnetic interference by maintaining a minimum distance between the mobile and
portable RF communications equipment (transmitters) and the Isis as recommended below, according to the maximum output power of
the communication equipment.
Distance of separation according to the frequency of the transmitter (m)
150 kHz to 80 MHz
outside ISM bands
150 kHz to 80 MHz
outside ISM bands
80 MHz to 800 MHz
800 MHz to 2.5 GHz
0,01
0,35
1,2
0,12
0,23
0,1
1,1
3,8
0,38
0,73
1
3,5
12
1,2
2,3
10
11
38
3,8
7,3
100
35
120
12
23
Maximum output power
of the transmitter (W)
For transmitters with a maximum output power not listed above, the advisable separation distance “d” in meters (m) can be determined
by using the equation applicable to the frequency of the transmitter, where “P” is the maximum output power of the transmitter in watts
(W) according to the transmitter manufacturer.
NOTE 1: At 80MHz and 800MHz, the separation distance for the highest frequency range is applied.
NOTE 2: The ISM (industrial, medical and scientific) frequency bands between 150kHz and 80MHz are 6.765MHz to 6.795MHz; 13.553
MHz to 13.567MHz; 26.957MHz to 27.283MHz; and 40.66MHz to 40.70MHz.
NOTE 3: An additional factor of 10/3 is used in calculating the advisable separation distance for transmitters in the ISM frequency
bands between 150kHz and 80MHz and in the frequency range 80MHz to 2.5GHz to reduce the likelihood of interference that mobile/
portable communications equipment could cause if taken inadvertently to patient areas.
NOTE 4: These directives may not be applicable in all situation. Electromagnetic transmission is affected by the absorption and
reflection of structures, objects and people.
48
User manual | Precautions, restrictions and warnings
ECG analysis algorithm
Databases used for the VF/VT recognition algorithm tests:
• MIT-BIH Arrhythmia Database.
• MIT-BIH Atrial Fibrillation Database.
• MIT-BIH Supraventricular Arrhythmia Database.
• European Society of Cardiology Arrhythmia Database.
• Creighton University Arrhythmia Database.
Test report:
• Recording Methods: the files were acquired via internet through the MIT-BIH
database and used via computer.
• ECG Rhythm Sources: MIT-BIH, on http://ecg.mit.edu/
• Rhythm Selection Criteria: rhythms were chosen according to notes present in
the MIT-BIH database.
• Criteria and Annotation Methods: the rhythms were recognized and annotated
in a separate file. Later they were recognized and compared for sensitivity and
specificity calculations.
Shock INDICATED
NO shock INDICATED
VF/VT
Nonshockable Rhythms
A
B
C
D
Sensibility=
A
A+C
Specificity=
D
B+D
49
User manual | Precautions, restrictions and warnings
Sensitivity is the equipment’s percent ability to correctly identify a shockable rhythm.
Specificity is the equipment’s percent ability to correctly identify a nonshockable
rhythm.
A = True Positive
B = False Positive
C = False Negative
D = True Negative
A true positive (A) is the equipment’s ability, in measurement units, to correctly
identify a shockable rhythm.
A false positive (B) is the equipment’s ability, in measurement units, to wrongly
recognize a shockable rhythm.
A false negative (C) is the equipment’s ability, in measurement units, to wrongly
recognize a nonshockable rhythm.
A true positive (D) is the equipment’s ability, in measurement units, to correctly
recognize a nonshockable rhythm.
Values measured with the AED using the specified database:
Shock INDICATED
NO shock INDICATED
VF/VT
Nonshockable
Rhythms
329
23
10
454
Sensibility = 97.05%
Specificity = 95,18%
50
User manual | Precautions, restrictions and warnings
Types of arrhythmia analyzed
Nonshockable:
• Sinus Rhythm/ Sinus Tachycardia/ Sinus Bradycardia;
• Atrial Tachycardia;
• Atrial Fibrillation;
• Atrial Flutter;
• Supraventricular Tachyarrhythmia;
• Normal Rhythm with Extrasystoles;
• Sinus Rhythm with Pacemaker;
• Asystole.
Shockable:
• Ventricular Tachycardia with several QRS amplitudes and widenings.
• Ventricular Fibrillation with several amplitudes.
Rhythm Classes
Specifications
Shock - VF
The Isis meets IEC 60601-2-4 requirements for
sensitivity > 90%
Shock - VT
The Isis meets IEC 60601-2-4 requirements for
sensitivity > 75%
Nonshockable rhythms
The Isis meets IEC 60601-2-4 requirements for
specificity > 95%
51
8
Specifications
General specifications
Dimensions:
22 cm (8.7 in ) (L)
13 cm (5.1 in) (W)
29 cm (11.4 in) (H)
Weight:
Equipment – 2.90 Kg (6.38 lbs)
Internal rechargeable battery:
Type: Li-ion, 14,4VDC 4,0 A/h
Life: 10 hours in cardiac rhythm
recognition mode (fully charged battery),
or a minimum of 200 shocks at 200
Joules.
Time to fully charge the battery (when fully
depleted): 5 hours.
Battery power supply charger :
AC 100 – 240 V/50-60 Hz
Consumption (maximum): Electric mains
supply 1A
Output: 24 VDC, 1,5 A
Battery storage:
Storing the battery for a long period of
time in temperatures higher than 35° C
(95° F) will reduce its capacity and shelf
life.
Pre-adjusted defibrillation scales:
Adults: 1st shock: 150J; next shocks:
200J
Children: 50 J
Internal memory storage:
100 events or 2 hours of ECG recording
Protection rating:
IPX0
Classification:
Internally Energized Equipment
CF type
52
User manual | Specifications
Functioning mode:
Continuous Operation
Maximum time from rhythm
analysis beginning to discharge
readiness:
20s
Maximum time from rhythm
analysis beginning to full
discharge readiness:
25s
Environmental specifications
Temperature:
Operational: 0 to 50ºC (32 to 122 ºF)
Storage: 0 to 70 ºC (32 to 158ºF)
Humidity:
Operational: 10 to 95% RH, without
condensation
Storage: 10 to 95% RH, without
condensation
Defibrillator
Waveform:
Biphasic truncated exponential. Wave
shaped parameters adjusted according to
the patient’s impedance
Shock application:
By means of multifunctional adhesive
pads
Commands:
Front Panel Button (on/off).
Scales for defibrillation:
Adult: 150 and 200 J
Child: 50 J
Adults/children Selection:
Automatic due to the size of the pads
53
User manual | Specifications
Charge command:
Automatic after identifying an arrhythmia
Shock command:
Front panel button, when blinking
Maximum time from rhythm
analysis beginning to discharge
readiness:
20s
Maximum charging time:
50 Joules: < 2 seconds
150 Joules: < 4 seconds
200 Joules: < 6 seconds
The rhythm detector and recognizer does not continue analyzing ECG after a
shockable rhythm is detected
Pads size:
Adult = area: 82 cm2 (32.3 in2)
Child = area: 30 cm2 (11.8 in2)
Maximum output voltage:
2000V
Maximum output current:
80A (25Ω)
54
User manual | Specifications
Precision of applied energy:
Impedance
Selected
energy
175
Accuracy
25
50
75
100
125
150
50
49,0
52,0
53,0
52,5
51,5
48,0
45,5 ±15%
150
143,0
151,5
155,0
153,0
148,0
141,0
137,0 ±15%
200
191,5
201,5
205,5
206,0
203,5
192,0
177,0 ±15%
Patient’s impedance response table:
Patient’s impedance
Shock
Short-circuit
Shock inhibited
< 25 Ohms
Shock inhibited
> 25 Ohms e < 300 Ohms
Shock delivered with a waveform adjusted to the
patient’s impedance
> 300 Ohms
Shock inhibited
Open circuit
Shock inhibited
ECG rhythm recognition and detector table:
VF and VT
All other ECG rhythms
Shock indicated
329
23
No shock indicated
10
454
Sensitivity: 97,05%
Specificity: 95,18%
Tests carried out with the MIT-BIH database.
55
User manual | Specifications
Values on the Y axis refer to voltage (volts) and values on the X axis refer to time
(milliseconds).
200J of energy at 25R impedance.
200J of energy at 50R impedance.
200J of energy at 75R impedance.
56
User manual | Specifications
200J of energy at 100R impedance.
200J of energy at 125R impedance.
200J of energy at 150R impedance.
57
User manual | Specifications
200J of energy at 175R impedance.
58
Inspection and Maintenance
Preventive Maintenance
9
Instramed recommends that the Isis be examined by a qualified technician
every 12 months. We recommend that you contact the manufacturer for more
information about qualified and trained personnel in your area to perform preventive
maintenance.
It is recommended that periodic inspections be performed on the equipment’s power
supply charger, cables and connectors in order to determine possible isolation or
internal conductor ruptures.
Remember to check the status of the operational status indicator at least every 30
days (see page 18 - operational status indicator).
Corrective Maintenance
If the equipment needs repair, this can only be done by INSTRAMED or its
authorized representative, otherwise this Warranty certificate may no longer be
valid.
No internal parts are to be fixed by the user.
ATTENTION: periodic maintenance is needed independently of the equipment’s
use frequency.
59
10
Warranty Certificate
Instramed Indústria Médico Hospitalar Ltda. warrants the equipment
described in this Certificate for 12 (twelve) months, starting from the delivery
date. This warranty covers manufacturing or material defects that prevents proper
functioning according to the specifications stated herein, as long as the conditions
presented in this Certificate are respected.
During the warranty period, Instramed Indústria Médico Hospitalar Ltda. or
its representative will repair or replace defective parts, at no expense to the
equipment’s owner.
This warranty will no longer be valid if any damage occurs due to accident,
natural disaster, improper connection to a power source, use distinct from
that described in the User manual, or irregular working conditions.
Any attempt to violate, adjust or repair this equipment by individuals not
authorized by Instramed Indústria Médico Hospitalar Ltda. will automatically
invalidate this warranty. This also applies in case of alterations made to this
contract, the fiscal receipt, or to the equipment’s serial number.
Instramed Indústria Médico Hospitalar Ltda. is not responsible for the improper use
of this equipment, by people who are not familiar with its function or the techniques
recommend for its proper use.
EQUIPMENT :_______________________________________________________
SERIAL NUMBER:___________________________________________________
PURCHASE DATE:___________________________________________________
FISCAL RECEIPT NUMBER:___________________________________________
60
AUTOMATED EXTERNAL DEFIBRILLATOR
www.Instramed.com.br
+55 (51) 3073 8200